(19 days)
Vitros Chemistry Products CRP Slides For in vitro diagnostic use only. Vitros Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma. Vitros Chemistry Products Calibrator Kit 7 For in vitro diagnostic use only. Vitros Calibrator Kit 7 is intended for use in the calibration of the Vitros Chemistry Systems for the quantitative measurement of CRP.
The Vitros Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multilayered analytical element of a Vitros slide. The system is comprised of two main elements: 1. The range of Vitros Chemistry Products (in this case Vitros Chemistry Products CRP Slides and Vitros Chemistry Products Calibrator Kit 7), which are combined on the Vitros Chemistry System to perform the Vitros CRP assay. 2. The Vitros Chemistry System - instrumentation, which provides automated use of the chemistry slides. Vitros 250 and 950 Chemistry Systems were cleared for market by separate 510(k) pre-market notifications (K922072 and K946090, respectively). The Vitros Chemistry System and Calibrators are dedicated specifically for use only with the Vitros Chemistry Products range of products. The Vitros System uses common reagents. The Vitros Chemistry Products Specialty Diluent and Vitros ImmunoWash fluid were cleared by previous 510(k) pre-market notification (K962235 and K942610, respectively).
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the VITROS Chemistry Products CRP Slides:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it demonstrates substantial equivalence to a predicate device. The performance is assessed by comparing key characteristics and showing that the modified device performs similarly or equivalently.
| Device Characteristic | Predicate Device (Current Vitros CRP Slide) | New Device (Modified Vitros CRP Slide) | Equivalence/Performance |
|---|---|---|---|
| Sample Volume | 11 µL | No Change (Implies 11 µL) | Equivalent |
| Wash Volume | 12 µL | No Change (Implies 12 µL) | Equivalent |
| Intended Use | For in vitro diagnostic use only. Vitros CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma. | No Change (Same intended use) | Equivalent |
| Basic Principle | Dry multi-layered slide utilizing reflectance spectrophotometry. | No Change (Same basic principle) | Equivalent |
| Sample Type | Serum, Plasma (lithium heparin, sodium citrate and EDTA) | Serum, Plasma (heparin and EDTA) | Similar, with a slight narrowing of accepted plasma types (sodium citrate explicitly removed from new device description). However, the overall conclusion is still substantial equivalence. |
| Reportable Range (Serum, Plasma) | 0.7 - 11.0 mg/dL (Conv. Units) / 7 - 110 mg/L (SI Units) / 700 - 11000 ug/dL (Alt. Units) | 0.3 - 11.0 mg/dL (Conv. Units) / 3 - 110 mg/L (SI Units) / 300 - 11000 ug/dL (Alt. Units) | Improved lower detection limit (0.3 mg/dL vs 0.7 mg/dL). This is an improvement over the predicate, making it effectively equivalent or better in this aspect, which supports substantial equivalence. The upper limit remains the same. |
| Instrumentation | Vitros 250 and 950 Chemistry Systems | No Change (Same instrumentation) | Equivalent |
| Incubation time and temperature | 7.5 minutes at 37°C | No Change (Same incubation time and temperature) | Equivalent |
| Immobilized phosphorylcholine | 0.07 mg per cm² | No change (Implies 0.07 mg per cm²) | Equivalent |
| Anti-CRP antibody labeled with HRP | 0.0009 units per cm² | 0.0006 units per cm² | Different, however, the study concluded that despite this change, the overall performance (including the improved reportable range) demonstrates substantial equivalence. The implication is that this formulation change does not negatively impact performance but rather contributes to the improved lower detection limit. |
| Calcium chloride | 0.10 mg per cm² | 0.08 mg per cm² | Different, but similar to the anti-CRP antibody, the study concluded that the overall performance is substantially equivalent. |
| Leuco dye | 0.04 mg per cm² | No change (Implies 0.04 mg per cm²) | Equivalent |
Study that Proves the Device Meets Acceptance Criteria:
The study described is an equivalence study designed to show that the "Vitros Chemistry Products CRP Slides (modified)" are substantially equivalent to the "Vitros Chemistry Products CRP Slides (current/predicate)."
- Study Design: The information provided describes a comparison study between the new device and the predicate device. Equivalence was demonstrated by testing manufactured slides with patient and quality control samples.
- Performance Metrics: The implied performance metrics are the various assay characteristics listed in Table 1, particularly the reportable range and the ability to measure CRP values across that range accurately compared to the predicate. The key 'acceptance criteria' is the demonstration of substantial equivalence, which means the device performs at least as well as the legally marketed predicate device, and any differences do not raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the test set. It mentions "patient and quality control samples," but no specific numbers are given.
- Data Provenance: Not specified. There is no mention of the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Ground Truth Establishment: For in vitro diagnostic assays like this, the "ground truth" is typically established by comparing results to a reference method or another already cleared device (in this case, the predicate device itself acts as the benchmark for comparison, along with quality control materials that have known values). It's not usually established by human expert consensus in the same way an imaging AI would be.
4. Adjudication Method:
- Adjudication Method: Not applicable in the context of this type of in vitro diagnostic device comparison study. Adjudication methods like 2+1 or 3+1 are relevant for interpreting ambiguous data (e.g., medical images) where human experts might disagree. For quantitative assays, the 'ground truth' is more objective (e.g., a measured concentration).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This is an in vitro diagnostic device for quantitative measurement of C-reactive protein, not a device requiring human interpretation of medical images. Therefore, MRMC studies and concepts of human readers improving with AI assistance are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in effect. The device (VITROS Chemistry Products CRP Slides used on the VITROS Chemistry System) is an automated system for measuring CRP concentration. Its performance is inherent to the reagent slides and the instrument, requiring no human interpretation or "human-in-the-loop" decision-making for the actual measurement process once the sample is loaded. The "algorithm" here is the chemical reaction and spectrophotometric measurement process validated by the manufacturer.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the "modified" device, the ground truth was established by comparison to the predicate device (VITROS Chemistry Products CRP Slides, current slide) using "patient and quality control samples with measured CRP values." Quality control samples typically have known, certified values. Patient samples would have their CRP levels independently measured, presumably by the predicate device or a recognized reference method, to assess correlation and accuracy.
8. The Sample Size for the Training Set:
- Sample Size: The document does not specify a separate "training set." For this type of IVD device, the term "training" is not typically used for algorithm development in the same way it would be for machine learning. Instead, the product development and manufacturing process would involve internal testing and optimization (sometimes referred to as verification and validation activities), but not a distinct "training set" of patient data in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as no "training set" is described for algorithm development in the AI sense. The development of the slides (including the modified reagent composition) would have been based on established chemical principles and optimization to achieve desired performance characteristics.
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Summary Information
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 103062
-
Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive Name, Rochester, New York 14626-5101 Address, (585) 453-4253 Contact
Contact Person: Darlene J. Phillips -
Date Special 510(k) prepared: 25 February2003 2. Preparation Date
-
Trade or Proprietary Name: 3. Device Vitros Chemistry Products CRP Slides name Common Name: CRP test Classification Name: C-reactive protein immunological test system (21 CFR 866.5270)
-
The Vitros Chemistry Products CRP Slides (modified) and Vitros 4. Predicate Chemistry Products Calibrator Kit 7 are substantially equivalent to the Vitros Chemistry Products CRP Slides (current slide) and Vitros Chemistry Products Calibrator Kit 7.
Continued on next page
Ortho-Clinical Diagnostics, Inc.
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510(k) Summary, Continued
| 5. Devicedescription | The Vitros Chemistry System uses Vitros Slides to perform discretechemistry tests on body fluid specimens. All reactions necessary for asingle quantitative measurement take place within the multilayeredanalytical element of a Vitros slide.The system is comprised of two main elements:1. The range of Vitros Chemistry Products (in this case Vitros ChemistryProducts CRP Slides and Vitros Chemistry Products Calibrator Kit 7),which are combined on the Vitros Chemistry System to perform theVitros CRP assay.2. The Vitros Chemistry System - instrumentation, which providesautomated use of the chemistry slides. Vitros 250 and 950 ChemistrySystems were cleared for market by separate 510(k) pre-marketnotifications (K922072 and K946090, respectively).The Vitros Chemistry System and Calibrators are dedicated specificallyfor use only with the Vitros Chemistry Products range of products.The Vitros System uses common reagents. The Vitros Chemistry ProductsSpecialty Diluent and Vitros ImmunoWash fluid were cleared by previous510(k) pre-market notification (K962235 and K942610, respectively). |
|---|---|
| 6. Deviceintended use | Vitros Chemistry Products CRP SlidesFor in vitro diagnostic use only.Vitros Chemistry Products CRP Slides quantitatively measure C-reactiveprotein (CRP) concentration in serum and plasma.Vitros Chemistry Products Calibrator Kit 7For in vitro diagnostic use only.Vitros Calibrator Kit 7 is intended for use in the calibration of the VitrosChemistry Systems for the quantitative measurement of CRP. |
Continued on next page
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510(k) Summary, Continued
The Vitros Chemistry Products CRP Slides (modified) 7. Comparison to and Vitros Chemistry Products Calibrator Kit 7 are substantially predicate equivalent to Vitros Chemistry Products CRP Slides (current) and Vitros device Chemistry Products Calibrator Kit 7 which were cleared by the FDA for in vitro diagnostic use with human serum and plasma. (K953197, cleared July 31, 1995)
Table 1 lists the characteristics of the tests performed using the Vitros Chemistry Products CRP Slides (modified) and Vitros Chemistry Products CRP Slides (current slide).
| Table 1 List of Assay Characteristics: Comparison to Predicate Device | ||
|---|---|---|
| Device Characteristic | New Device | Predicate Device |
| Device Characteristic | New DeviceVitros CRP Slide(Modified) | Predicate DeviceVitros CRP Slide(Current) |
| Sample Volume | No Change. | 11 µL |
| Wash volume | No change | 12 µL |
| Intended Use | No Change. | For in vitro diagnostic use only.Vitros CRP Slides quantitativelymeasure C-reactive protein (CRP)concentration in serum and plasma. |
| Basic Principle | No Change. | Dry multi-layered slide utilizingreflectance spectrophotometry. |
| Sample Type | SerumPlasma (heparin and EDTA) | SerumPlasma (lithium heparin,sodium citrate and EDTA) |
| Reportable Range Serum, Plasma | 0.3 - 11.0 mg/dL (Conv. Units)3 - 110 mg/L (SI Units)300 - 11000 ug/dL (Alt. Units) | 0.7 - 110.0 mg/dL (Conv. Units)7 - 110 mg/L (SI Units)700 - 11000 ug/dL (Alt. Units) |
| Instrumentation | No Change. | Vitros 250 and 950 Chemistry Systems |
| Incubation time and temperature | No Change. | 7.5 minutes at 37°C |
| Slide Reactive Ingredients per cm2: | ||
| Immobilized phosphorylcholine | No change | 0.07 mg |
| Anti-CRP antibody labeled with HRP | 0.0006 units | 0.0009 units |
| Calcium chloride | 0.08 mg | 0.10 mg |
| Leuco dye | No change | 0.04 mg |
Continued on next page
Vitros Chemistry Products CRP Slides Vitros Chemistry Products Calibrator Kit 7
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510(k) Summary, Continued
The information presented in the pre-market notification demonstrate 8. Conclusion that the performance of the Vitros Chemistry Products CRP Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured CRP values spanning the reportable range.
The information presented in the premarket notification provide a reasonable assurance that the Vitros Chemistry Products CRP Slides (modified) is safe and effective for the stated intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the silhouettes of the profiles, creating a sense of unity and human connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, emphasizing the organization's name and national affiliation.
MAR 1 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Darlene J. Phillips Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
K030626 Trade/Device Name: VITROS Chemistry Products CRP Slide and VITROS Chemistry Products Calibrator Kit 7 Regulation Number: 21 CFR § 866.5270 Regulation Name: C-reactive protein immunological test systems Regulatory Class: II Product Code: DCK, JIT Dated: February 25, 2003 Received: February 27, 2003
Dear Ms. Phillips:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Statement of Intended Use
Page 1 of 1
| 510(k) Number (if known): | K030626 |
|---|---|
| Device Name: | Vitros Chemistry Products CRP SlidesVitros Chemistry Products Calibrator Kit 7 |
| Intended Use: | Vitros Chemistry Products CRP SlidesFor in vitro diagnostic use only.Vitros Chemistry Products CRP Slides quantitatively measureC-reactive protein (CRP) concentration in serum and plasma.Vitros Chemistry Products Calibrator Kit 7For in vitro diagnostic use only.Vitros Calibrator Kit 7 is intended for use in the calibration ofthe Vitros Chemistry Systems for the quantitative measurementof CRP. |
| Summary andExplanation of Test | C-reactive protein is synthesized by the liver and is one of theacute phase proteins. In the acute phase response, increasedconcentrations of a number of plasma proteins, including CRP,are observed. 1CRP concentration measurements are useful in the detection andevaluation of inflammatory disorders, tissue injury, andinfections. 2, 3 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Reeves for J. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030626
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)
Vitros Chemistry Products CRP Slides Vitros Chemistry Products Calibrator Kit 7
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).